RFP ANNOUNCEMENT: REGULATORY COMPLIANCE CENTER - NIH-NIAID-DAIDS-03-26
Release Date: April 10, 2002
NOTICE: NOT-AI-02-014
National Institute of Allergy and Infectious Diseases
(http://www.niaid.nih.gov)
Receipt Date: July 15, 2002
DESCRIPTION
The Division of Acquired Immune Deficiency Syndrome (DAIDS) of the National
Institute of Allergy and Infectious Diseases (NIAID), National Institutes of
Health (NIH), is recompeting their current contract with Social and
Scientific Systems, Inc., Contract Number N01-AI-65275. This solicitation
will be a 100% Small Business Set-Aside, NAICS Code 541710, 500 employees.
This new contract will be awarded as a performance-based contract with the
emphasis being on the contractor's ability to provide rapid response to
requests for support to the Division of AIDS. The DAIDS is seeking capable
small business organizations having regulatory, clinical and technical
expertise and facilities to provide the Regulatory Affairs Branch (RAB) in
DAIDS with regulatory and technical support to facilitate management of
regulatory aspects of DAIDS-sponsored clinical trials.
This critical contract will exist within a complex research environment and a
consortium of multiple clinical trials groups, which are increasingly
international in scope. International research is predominantly conducted in
countries with high prevalence of HIV/AIDS. The clinical trials networks to
be supported include, but are not limited to: HIV Vaccine Trials Network
(HVTN); HIV Prevention Trials Network (HPTN); Adult AIDS Clinical Trials
Group (AACTG); Pediatric AIDS Clinical Trials Group (PACTG); Evaluation of
Subcutaneous Proleukin in a Randomized International Trial (ESPRIT); The
Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA); and
Acute HIV Infection and Early Disease Research Program (AIEDRP). These
networks interact with a complex research environment composed of, but not
limited to, clinical investigators and their institutions, the statistical
and data analysis centers, operational centers of the networks, the Food and
Drug Administration (FDA), the Office of Human Research Protection (OHRP),
the Fogarty International Center (FIC), the pharmaceutical industry, local
and national Internal Review Board/Ethics Committees, patients with HIV/AIDS
and their advocates, populations at risk for HIV infection, and the DAIDS'
scientific and administrative personnel. These networks make key decisions
about HIV/AIDS treatment and prevention research and conduct numerous
clinical trials of all phases.
The clinical research organization must: (1) provide regulatory, clinical and
technical expertise to enable DAIDS to fulfill its responsibilities as a
sponsor of a large portfolio of Investigational New Drug (IND) Applications
and other large clinical trials not conducted under IND; (2) manage the
Serious Adverse Experience (SAE) System for both IND and non-IND studies of
all phases; (3) provide technical ability to write concept sheet and protocol
review summaries and related letters for DAIDS; (4) maintain the protocol
registration and informed consent review systems; (5) develop in
collaboration with DAIDS and the pharmaceutical industry lists of risks
associated with approved/investigational drugs/vaccines used in DAIDS-
sponsored clinical trials; (6) assist or lead in negotiation of clinical
trials agreements with pharmaceutical collaborators; (7) coordinate and
prepare for meetings and conference calls with the FDA, OHRP or other groups
collaborating with the networks and other such activities as may be necessary
to successfully conduct DAIDS-sponsored clinical trials; (8) establish and
maintain a computerized information system to produce reports and track
existing and evolving information related to major responsibilities of the
contract; (9) provide extensive international travel of contractor staff and
set up international conference calls for the purpose of providing updated
information about regulatory issues and site regulatory responsibilities;
and, (10) participate in electronic communication between DAIDS and clinical
trials groups' operational offices and sites for the purpose of information
exchange.
It is anticipated that the period of performance for this contract will be a
total of seven years to be award as a three-year base period with two, two-
year, options. Any responsible Offeror may submit a proposal that will be
considered by the Government. This advertisement does not commit the
Government to award a contract. No collect calls will be accepted. No
facsimile transmissions will be accepted.
RFP-NIH-NIAID-DAIDS-03-26 may be accessed through the NIAID Contract
Management Branch (CMB) Home Page at http://www.niaid.nih.gov/contract and
was posted on FedBizOpps.
Contracting Office Address:
National Institutes of Health
National Institutes of Allergy and Infectious Diseases
Contract Management Branch
6700-B Rockledge Drive
Room 2230, MSC 7612
Bethesda, MD, 20892-7612
Point of Contact:
Nancy Hershey, Contract Specialist, Phone 301-496-0193, Fax 301-402-0972,
Email nh11x@nih.gov
Barbara Shadrick, Senior Contracting Officer, Phone 301-496-7288, Fax 301-
402-0972, Email bs92y@nih.gov
This announcement does not commit the Government to award a contract. No
collect calls will be accepted.